AccessGUDID - DEVICE: Lions World Vision Institute (05056100712775)

GUDID

Device Identifier (DI) Information

Brand Name: Lions World Vision Institute
Version or Model: LWVI-850-6.00
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NETWORK MEDICAL PRODUCTS LIMITED

Primary DI Number: 05056100712775
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 458670304 *Terms of Use

Device Description: Donor Trephine Punch 6.00MM

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47088	Corneal punch set	A collection of surgical instruments intended to cut a precise circular section of the cornea (corneal button) from stored cadaveric donor tissue for transplantation into a prepared patient. It typically consists of a small base plate, an extremely sharp and hollow cylinder that has a thin circular cutting edge (a trephine), and a guide through which the trephine can travel. The surgeon typically places a section of corneal tissue into the centre of the base plate (it has a graduated inverse bowl emulating the curvature of the eye), assembles the guide and trephine into position, and applies pressure onto the trephine to cut the button. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HRH	Trephine, Manual, Ophthalmic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 499bc74a-9419-4618-a0ec-d1427e7115d2
Public Version Date: March 19, 2025
Public Version Number: 1
DI Record Publish Date: March 11, 2025